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Meet Xiidra: The Newest Dry Eye Therapy

9:40 AM

The last time a medication was approved for the treatment of dry eye syndrome? October 2003. That medication was the blockbuster Restasis, still commanding the dry eye marketplace 13 years later. Over those 13 years, we've learned a lot more about dry eye and the 16 million Americans that are diagnosed and treated for it every year. They suffer from symptoms like burning, watering, redness, blurry vision, and tired eyes. For many, even the best medical care available on the market is not enough to overcome their discomfort. That's why the world is so excited for a new medication on the market. Shire's Xiidra was FDA approved on July 12th for the treatment of the signs and symptoms of dry eye disease (Restasis is FDA approved to treat the signs of dry eye disease only). Slated to become commercially available this fall, there's still a lot about Xiidra that patients and eyecare providers don't know. We don't know the cost, we don't know exactly how patients will respond in our offices, we don't know how Xiidra will compete with Restasis, and we don't know how insurance coverage will look. Here's what we do know so far:

What It Is:Xiidra (lifitegrast 5%) is a non-steroidal anti-inflammatory eye drop, treating dry eye by disrupting the inflammatory cascade responsible for much of the discomfort and ocular surface changes associated with dry eye disease. It specifically targets intracellular adhesion molecule 1 (ICAM-1); Xiidra binds to proteins on the surface of white blood cells (leukocytes) where ICAM-1 would typically bind, thus blocking ICAM-1 from being able to attach and signal the inflammatory cascade. When ICAM-1 molecules bind to leukocytes, they signal T-cells (the body's main inflammatory cell unit) to the area. Xiidra prevents this binding, and thus T-cells aren't signaled to migrat to the ocular tissue. What does blocking the inflammatory cascade mean to you? Inflammation is what makes dry eye so miserable - redness, burning, and surface cell damage (called superficial punctate keratitis -- basically dried out corneal cells sloughing off the cornea creating symptoms like sharp pain and blurry vision).

What It Does:
In the clinical trials that earned Xiidra FDA approval, over 1000 people with dry eye disease were treated with Xiidra over the course of 12 weeks and the results were compared to placebo treatment. Patients being treated with Xiidra showed statistically significant improvement at Week 6 and Week 12 as compared to those on placebo eye drops in both the signs and symptoms of dry eye, as measured by a subjective symptom scoring questionnaire called the Eye Dryness Score (EDS) and inferior corneal staining (see superficial punctate keratitis above).

How It's Used:

Like Restasis, Xiidra is dosed 1 drop in both eyes 2 times a day.

Clinical trials suggest that Xiidra will begin improving both the signs and symptoms of dry eye as early as 6 weeks into treatment, much faster than Restasis whose clinical trials showed improvement in signs of dry eye (judged by Shirmer score) at 6 months versus placebo.

Xiidra and Restasis both target the inflammatory cascade, but they do not target the same molecules so there is no scientific data that suggests they could not be used in combination.

Xiidra is pregnancy category C (meaning it was not tested for safety)

Xiidra is approved for ages 17 and up

Xiidra is not approved for use with contact lenses; you must remove contact lenses before insertion and wait 15 minutes before reinserting them.

Now that Xiidra is FDA approved, Shire has the task of setting the price for the medication and working with government and insurance coverage. Cash price for competitor Restasis is currently over $400 for a 30 day supply when using 2 vials a day. Analysts expect Xiidra will be priced similarly. There is debate that Xiidra may try to come in slightly lower to directly compete with Restasis, but there are also analysts predicting Xiidra will come in slightly above Restasis in cost since they have a significantly faster method of action and Xiidra is also approved to treat the symptoms of dry eye while Restasis is not.

Stay tuned as more information become available we will continue to report on this exciting new treatment option!

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23
comments

I tried Xiidra today and was very underwhelmed. There were 5-6 drops, drops were very liquidy with minimal viscosity, and vial could not be resealed. In comparison, the Restasis vial was resealable and dispensed 8-9 large viscous drops - easy to know it was placed in eye, less likelihood of drop loss, could easily last an entire day for both eyes. As for dysgusia, 4/4 of us experienced a very foul taste from anywhere to 15-60 minutes after use. As a prescriber, I take very personally the what I believe intentional crappy vial manufacturing, as this leads to more cost to the patient and more cash to Shire. I will not be prescribing this medication until the vials are changed.

I must respectfully disagree with the comments of Scott. I have a problem with the viscosity of both Restasis and Lotemax. The substances go into the eye and as soon as you blink most of it comes out. Well at least that's my experience. Also, after putting these viscous drops in my eye I have a feeling like I have an eyelash in my eye. After a lot of discomfort a long string of sticky film comes out of the corner of my eye. With Xiidra I have most of the drop staying in my eye not blinking out. There is no feeling of eyelash and no string comes out. Yes there is a thin filmy effect for a short time but all in all a much better more comfortable experience. It's easier to live with a bad taste and film than with pain in my eye.

I have just begun taking Xiidra and am surprised at how well it is already working. My dry eye issues are fairly severe and I have also had two pingueculas removed. My eyes are not only incredibly dry but also red. After just two days on Xiidra, most (not all) of my redness is gone and I can go the entire day without my eyes feeling tired or dry! I do have one minor side effect... a slight headache...we'll see if that persists, but for me, I'll take the headache any day of the week over the past dryness that I have experienced...thank you Shire for finally coming out with something that works for me.

This is a very common side effect! To help limit the chance you get this bad after taste, close your eyes for 30 seconds after you put the drop in. You can also put a finger over the inner corner of the eye and hold it there. This helps limits how much drop will drain down the back of your throat, and most patients have told me they get less bad taste issues if they take this extra step.

Xiidra is amazing. I have dry eyes to the extend that my cornea was damaged enough to require PRK twice to remove scarring. I've been on Restasis for a few years and while it helps I don't think it does much as I was still using a large amount of Systane Ultra and eye gels at night. After less than one week on my trial pack of Xiidra I was down to using at most 10% of the OTC drop volume and rarely felt dry at all--almost total symptom remission! My insurance (good commercial insurance--HAP in Michigan) does not cover this drug, unfortunately. Shire has a discount program which gives you the first month to get hooked on the drug then the cash price is still $211/month after their discount. This is absolutely ridiculous. Thank you, Shire, for developing an amazing product that tens of millions of people could benefit from and excluding the vast majority of consumers due to price. This is one case where you really could make up the difference on volume---why not undercut an inferior product (Restasis) on price so insurers will actually cover it?Mike vxmike@gmail.com

It depends on how long you were taking it for. If you were on it for weeks, it'll affect you for longer than if you were on it for a few days. If your eyes are really stuck and matted together there's a chance it's not a medicine side effect, but an infection. So if things are getting worse or not improving you should see your doctor.

I have had dry eyes for several years, first thought it was my glasses or cataracts. Dr prescribed Xiidra. I got the first month free with the coupon. From the beginning they burned my eyes, they were thick feeling and I had a discharge. I would wake up with crusty eyes and itchy. The taste never went away and everything I ate tasted weird. I finally insisted that the Dr prescribe Restasis. What a difference. No taste, no burning, eyes feel better all day, no discharge, no itching, and best of all my insurance pays for it and would not pay for Xiidra. I will stay with Restasis!!

I've been on Ziidra for 2 weeks and I am definitely seeing improvement. I reduced my lotemax to once a day earlier in the week and now am trying to go without it completely. The only problem I am having as it seems to run out of my eye. I try to keep my eyes closed for about 30 seconds and roll my eye around--I want it to do the most good. Any suggestions on that? Also, I know you are not supposed to keep it but I keep it standing up in the groves of an egg slicer and cover vial with a clean tissue and use again at night. My insurance does not cover it (Medicare) and there is no reduced price for Medicare--ridiculous almost $500 a month, which is out of the question for me. I am hoping to be well with the free month which I'm pushing to 2 months. The taste goes away quickly so it's not a big deal for me. The burning has also subsided since the first days--I am hopeful it is because my eyes are getting better.

I've had a very adverse reaction to Xiidra and would ask others to beware of this medication. I have always had crystal clear 20/20 long distance vision & only needed reading glasses for small print , all of this confirmed by my Dr at my last yearly eye exam Oct 2016. At that appointment I asked for something for my dry eye & he prescribed Xiidra , which I took for 5 days and stopped because suddenly my world was a complete & permanent blur . I immediately returned to my Dr who checked my vision and saw that it had in fact drastically changed. I went back 6 weeks later and it was worse ! We both wrote to Shire with no response. After another two months an eye exam showed it had not improved and in one eye is worse . I'm extremely sensitive to light now and I'm very frightened that my vision is slowly deteriorating. I would not recommend this medication under any circumstances !!

Definitely your doctor should report possible side effects to the FDA for further evaluation. There hasn't been any reported incident like what you've described in the clinical literature published so far, so a full investigation is needed to determine any link between the drop and your vision changes. You can find the published known side effects (like burning and bad taste) linked above, but vision loss has never been documented in thousands of cases. A full report to the FDA should be step one.

I am on day 2 of using Xiidra. So far, my eyes feel a little better, but the taste is awful. 2 hours later and I can still taste it. Had to chew ginger candy to help with upset stomach. Not sure this awful taste is worth it. Especially since after the first free month I would have to pay $200 per month?? That's ridiculous.

I am on day 2 of using these drops and although my eyes feel a little better the taste in my mouth is awful, and I put the drops in two hours ago! I even put my finger near nose to prevent drops from going down throat but that doesn't help. As soon as I stood up and started walking around the nasty flavor starting draining down into my throat and stomach. Had to chew ginger candy for an upset stomach. Not sure these drops are worth it, especially since after the first free month I may have to pay $200 each month. That's not going to happen. Very disappointing.

Maybe -- it's possible to have sensitivity reactions to Xiidra, but if your eye isn't red or irritated feeling, the watering might be a normal part of your tear film improvement. It takes Xiidra about 6 weeks to have a full clinical effect. I'd follow up with your doctor with any concerns!

HI! I am on xiidra for about 15days...but I feel that after using xiidra my eyes got drier specially my right eye...should I stop using the med? or continue using it for a month?? I had very high hopes in xiidra and very disappointed... do you think I will get better if I continue dropping it to my eyes? I wonder if eyes get worse before getting better..

According to the FDA study it takes around 6 weeks of use to achieve clinically significant results. It is possible to have an allergy to Xiidra, so best to consult with your doctor if you are in any discomfort.

I love Xiidra! I have Sjogren's Disease. The 2nd or 3rd week of using the meds I did have the right eye watering all the time. It has gotten better and not happening now after 2 months. No bad taste in my mouth. The only thing that is a concern is that with arthritis the plastic on the vial ampules are hard to press. I wish it had a more pointed end on the ampule. I miss my left eye and waste drops that way. I used Restasis for over 2 years. With the Sjogren's it did not help my dry eyes and it also burned unmercifully. My insurance company would only approve Xiidra for the rest of 2018 and then I have to go through the process again. I will take Xiidra over Restasis any day.